Knowledge acquisition group capabilities 2014 q1 (concise)
Annexure-I About Harrisons Tech Consultants
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ABOUT HARRISONS TECH CONSULTANTS
Harrison’s Tech Consultants Group, incepted in 1983 is a well Reputed Organization under the
leadership of Mr. Avinash C. Dua, an experienced pharmaceutical (GMP) professional having four
decades of Drug and Cosmetics Pharmaceutical experience. He is now joined by Ms. Deepti Dua
Goel, a well experienced Clinical Research (GCP) professional with specialization in Project
Management, Training and Development, Site Management and Regulatory services.
Harrisons has successfully provided consultancy to well reputed pharmaceutical companies like
Panacea Biotec, Aromamagic ( Blossom Kochar group), Brawn Pharmaceuticals, Dabur Pharma etc
“Harrisons” has successfully spread its wings and is a large group comprising of various diversified
yet related firms. These firms are Harrison’s Pharma Machinery Pvt. Ltd and Harrisons Hotel
Equipments Pvt. Ltd.
OUR CORE SERVICES:
1. PROJECT MANAGEMENT:
Being a certified PMI Professional and having spent considerable years in hard core project
management handling various types of clinical projects in the Industry, we support clients with
project management activities right from start of the project till close out. We have an expertise in
handling phased trials as well as non regulated studies. Overall coordination and management of
clinical trials
Generate master trackers, project management plans and collaborate with major
functional areas to identify and evaluate issues on the project and ensure implementation
of timely solutions
Identify, Hire (Support) and train resources, and time to time coach them per project
needs, track performances via weekly calls/updates and provide regular updates to
management at said periodicity.
Identify, Hire (Support) and train resources, and time to time coach them per project
needs, track performances via weekly calls/updates and provide regular updates to
management at said periodicity
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Track project budgets and generate contingency /risk mitigation plans in consultation with
management
Accountability for ensuring all project deliverables meet customers’ expectations.
This could be done office based or virtually- depending on what customer expect
2. TRAINING AND DEVELOPMENT:
Customized site training services for corporate clients.
On/Off site training workshop for Sites, Ethics Committees.
Actively engaged in Corporate Training Programmes independently also with government and
private sites. To name a few, these are Lady Hardinge Medical College, Delhi, Sataguru Pratap
Apollo Hospital, Ludhiana, Sri Balaji Action hospital, Delhi etc
CORPORATE TRAINING PROGRAMMES:
With our Indian regulatory environment going through rapid changes, it is imperative that all
key stakeholders get relevant trainings and share learnings and experience at a common
platform. With a strong background of handling such programmes independently for key
stakeholders like Sites, CRO, Sponsor, EC and lab: this group is actively engaged and
committed to hold region/national level certified programmes on request.
Programmes are led by highly experienced and opinion leaders and personal attention is paid
to the selection of faculties, development of course content and obtaining and post workshop
analysis of feedback and work on actions if required. Some of the key topics on which training
already imparted:
Latest Advancement in Clinical Research Regulatory environment in India
Tenets of GCP with focus on key responsibilities of key stakeholders.
Informed consent process in Clinical Trials
GCP and Schedule Y- key aspects
3. GCP CONSULTANCY:
o Setting and Developing Sites and ECs.
o Reviewing & Writing relevant Standard Operating Procedures (SOPs) for Sites in
accordance with regulatory requirements and GCP.
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Training & Certification of Investigators/Ethics Committee members covering GCP, Recent
Regulatory amendments, Roles & Responsibilities of EC, Monitoring at trial sites by EC,
Study conduct and management.
4. GCP AUDITS:
On request, we conduct process adequacy audits at sites and Ethics Committees. The point is to
have independent examination of people, process and technology ( if applicable) and assess
adequacy and provide gap analysis to the customer. Hence these independent checks help us
achieve these requirements.
5. SOP DEVELOPMENT & REVIEW:
SOPs play a pivotal role in any regulated Industry and it is therefore essential that they are
understood and followed by all end-users in a clinical trial. If SOPs are not followed correctly,
the validity of data generated is compromised; leading to warning letters being issued and
delays in the trial process. Also, with latest changes that have taken place, it is imperative that
SOPs made by all stake holders are relevant, updated and team if constantly trained and the
same is appropriately documented.
Since this is resource exhaustive and time consuming step, identify the list of mandatory SOPs in
collaboration with you, develop SOPs, update the existing ones and also carry out a periodic SOP
training of employees with assessment.